An interventional study of CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) in Substance Use Disorders, sponsored by St. Louis University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by St. Louis University · Not applicable, Interventional, and Prevention
The goal of this pilot trial is to test the feasibility and acceptability as well as efficacy of the adapted intervention, CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) among women will illicit polysubstance use participating in a court-mandated jail-based 90-day substance use disorder treatment program. The main questions it aims to answer are:
Researchers will compare the CHOICES-PLEAS intervention to a control condition to see if participation in the intervention reduces risk of substance exposed pregnancy, increases motivation to change substance use, and reduces risk of risky sexual behaviors.
The investigators will recruit 90 female participants from one of two jail-based SUD treatment programs: the court-mandated substance use disorder treatment program (CM-SUDTx) or the Medication for Addiction Treatment (MAT) Program to participate in pilot testing of the intervention, CHOICES-PLEAS. Research staff will describe the study at an initial CM-SUDTx meeting or with MAT program participants and invite interested women to meet with staff individually after their treatment session to be screened for eligibility. Over a 2.5-year period, there are ten 90-day CM-SUDTx cohorts, each with approximately 15 women (150 total). The investigators expect 130 women (13/cohort, 87%) to meet eligibility criteria. Of those eligible, the investigators expect about 9/cohort will enroll and complete the intervention based on pilot work indicating about 70% of CM-SUDTx participants are interested in research. Women in the MAT program have a diagnosis of OUD with or without additional substance use. The same inclusion criteria will be used to determine eligibility with the addition of participants needing to be confined between 2 and 6 months to allow time for study procedures to take place during incarceration.
The investigators will randomize the ten CM-SUDTx cohorts to receive CHOICES-PLEAS (45 women) or brief advice and referral (45 women) over a 2.5 year period using a matching process before randomization to achieve balance between cohorts in the intervention and control groups. The treatment cohorts will be divided into two cells by program start time within the study period (Year 2 quarter 2 through Year 4 quarter 3). The first 5 cohorts will be placed in cell one and the second 5 cohorts in cell two. Cohorts will be randomly selected within each of these two cells to be assigned to either the intervention or control group to ensure 5 cohorts will receive CHOICES-PLEAS (9 women per cohort, n=45) and 5 will receive brief advice and referral (9 women per cohort, n=45). Participants recruited from the MAT program will be randomized by individual.
All participants will complete a baseline survey before the intervention. The investigators will collect comprehensive participant contact information for all participants after participants complete a baseline survey. The 5 treatment cohorts and MAT program participants randomized to receive the intervention (n=45 women, 9 per cohort over 2.5 years) will participate in CHOICES-PLEAS. Research staff will administer the three motivational interviewing sessions one-on-one over an 8-week period. Referral and scheduling of a family planning appointment will take place in session 1 and the appointment may be scheduled at any time prior to completion of the CM-SUDTx or release from jail.
The 5 treatment cohorts and MAT program participants randomized to the control group (n=45 women, 9 per cohort over 2. years) will receive brief advice and referral consistent with other studies testing a similar intervention that includes general information about healthy lifestyle for women as well as a referral guide to local resources.
At completion of the CM-SUDTx or prior to release from jail, all participants will complete a survey. Women will be asked to review and update their contact information sheet and the one-month booster session and three-month assessment will be scheduled.
At 1-month post release, participants randomized in the intervention group will participate in a one-on-one motivational interviewing booster session at a convenient location. At 1- and 3-months post-release, all participants will complete an in-person assessment at a convenient location where they will complete a survey to measure continuation in treatment, provide a urine drug screen and pregnancy test, and reassess all measures collected at the time of release.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 90 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →St. Louis University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the experimental arm will receive the motivational interviewing intervention, CHOICES-PLEAS which consists of three one-on-one sessions and one family planning referral visit during incarceration and one booster session at one month after release from jail.
Behavioral: CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)
Participants in the active comparator will receive a control condition that consists of a booklet with general information about healthy lifestyle for women as well as a referral guide to local resources.
CHOICES-PLEAS includes four manual-guided motivational interviewing sessions delivered by a trained counselor and one family planning counseling session delivered by a family planning clinician. The intervention is based on the Transtheoretical Model (TTM) of behavior change and motivational interviewing that includes a decisional balance exercise, goal self-selection, self-monitoring, self-generated plans, and importance and confidence scales. By using a patient-centered approach based on the TTM that meets patients where they are, counselors can have a more effective impact on patient behaviors. This adaptation from the original CHOICES intervention contains unique features focused on the incarcerated setting, illicit polysubstance use, and risky sexual behaviors most common among women with illicit polysubstance use.
Number of participants with a change in risk of substance exposed pregnancy compared to baseline using Timeline Followback method assessing substance use and risky sexual behaviors
Defined as continued drug abstinence, absence of risky sexual behaviors, or both
Time frame: one and three months after release from jail
Self-efficacy to change substance use
Self-efficacy will be assessed using the single item Abstinence Self-Efficacy scale with scores ranging from 1-10 with higher scores indicating higher confidence.
Time frame: one and three months after release from jail
Self-efficacy to change risky sexual behavior
Self-efficacy will be assessed using the adapted 18-item Self-efficacy for Birth Control and Condom Use Scale with scores 18 - 90, with higher scores indicating higher confidence.
Time frame: one and three months after release from jail
Readiness to change substance use
Readiness to change will be assessed using the adapted 12-item Readiness to Change Questionnaire for substance use with scores from 12 to 60 with higher scores indicating higher levels of readiness.
Time frame: one and three months after release from jail
Readiness to change risky sexual behavior
Readiness to change will be assessed using the adapted 11-item Readiness to Change Questionnaire for risky sexual behaviors with scores from 11 to 55 with higher scores indicating higher levels of readiness
Time frame: one and three months after release from jail
Decisional balance to change substance use
Decisional balance will be assessed using the 20-item Decisional Balance Scale for substance use. Each question asking about importance of making a decision is rated from 1 to 5, with 5 being extremely important and 1 being not important at all. A difference score is calculated by subtracting scores of the cons of substance use from the pros of substance use. Positive numbers indicate endorsing more pros than cons for substance use.
Time frame: one and three months after release from jail
Decisional balance to change contraception use
Decisional balance will be assessed using the 20-item Decisional Balance Scale for contraception use. Each question asking about importance of making a decision is rated from 1 to 5, with 5 being extremely important and 1 being not important at all. A difference score is calculated by subtracting scores of the cons of using contraception from the pros of using contraception. Positive numbers indicate endorsing more pros than cons for using contraception.
Time frame: one and three months after release from jail
Participant acceptance of and satisfaction with the intervention
Measured using the 8-item Client Satisfaction Questionnaire (CSQ-8) with scores ranging from 8 to 32, with higher numbers indicating greater satisfaction. Five open ended questions about the intervention will also be administered.
Time frame: 90 days
Feasibility of delivering the intervention in the 90-day substance use disorder treatment program
Feasibility will be measured using the Working-Alliance Inventory measure. Twelve items are answered by the participant and 12 items are answered by the therapist. Scores for each 12-item subscale range from 12 to 84 with higher scores indicating greater therapeutic alliance.
Time frame: 90 days
Plan to share: Undecided — The IPD sharing plan is still in development.
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